Department of Health and Human Services January 28, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements regarding animal proteins prohibited in ruminant feed.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The National Biodefense Science Board (NBSB or the Board) is authorized under Section 319M of the Public Health Service (PHS) Act, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department of Health and Human Services (HHS) regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Authority to manage and operate the NBSB, including to receive advice and recommendations from the Board, has been delegated by the Secretary of HHS to the Assistant Secretary for Preparedness and Response (ASPR). The NBSB will meet in public (virtually) on March 7, 2022, beginning at 12:30 p.m. Eastern time. ASPR invites stakeholders and the general public to attend and participate as appropriate. A detailed agenda and instructions to register to attend the meeting will be available on the NBSB meeting website https://www.phe.gov/nbsb. Procedures for Public Participation: Members of the public may attend the meeting via a toll-free phone number or Zoom teleconference, which requires pre-registration. The meeting link to pre-register will be posted on the meeting website https://www.phe.gov/ nbsb. Members of the public may provide written comments or submit questions for consideration by the NBSB at any time via email to NBSB@hhs.gov. Additionally, the NBSB invites stakeholders to request up to seven minutes to address the Board in-person during the meeting. The Board is interested in hearing from anyone involved in, or who represents, a relevant biomedical, biodefense, or health security industry; serves as faculty or conducts research at an academic institution; occupies a relevant health profession or works for a hospital system or health care consumer organization; or who serves in a relevant state, Tribal, territorial, or local government agency. Requests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by March 1, 2022. In that request, please provide the speaker's name, title, and position, with a brief description of the topic that they will address. The number of speakers and topics will be based on relevance to the mission of the NBSB and amount of time available on the agenda. The charter of the NBSB may be reviewed on the ASPR/NBSB website. Topics and presentations with an obvious commercial bias, to include any form of advertising, marketing, or solicitation, will not be accepted.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $3.6 million funding with an expected total funding of approximately $18 million over a 5-year period to Michigan State University. The award will support activities related to the Flint Registry, a comprehensive public health registry of residents who were exposed to lead-contaminated water in Flint, Michigan.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with our Foreign Supplier Verification Programs for Food Importers.